1. Field of the Invention
The present invention relates to a wound dressing garment shaped to conform to the contours of body parts and, more particularly, to a dressing garment lined with a self-adhesive sheet-like gel layer forming an inner surface that directly contacts the wound and skin.
2. Description of the Related Art
Various gel-like materials are known to have properties that promote the healing of wounds such as severe burns. Sheet-like wound dressings having a self-adhesive layer formed of a gel material have been used to treat skin wounds by placing the gel material in direct contact with the wound. These dressings are secured to the wound via adhesion of the gel material to healthy skin surrounding the wound. The gel materials are typically tacky to the touch and readily adhere to the skin, but are easily removed from the skin without significantly pulling the skin or disturbing or clinging to newly formed tissue at the wound site, and leave no perceptible residue. These gel materials tend to manage fluids seeping from the wound in a manner conducive to healing and can be used to deliver additives such as anti-microbial agents to the tissue of the wound to prevent infection. In effect, such gel layers operate to seal the wound and function as a synthetic skin.
For example, U.S. Pat. No. 4,661,099 to von Bittera et al., incorporated herein by reference in its entirety, discloses a self-adhesive sheet-like structure having a support layer and an adhesive polyurethane gel layer which adheres to the skin and leaves virtually no residue when removed. The sheet-like structure can be used as a wound dressing in which a gauze bandage is held in place on the wound by the polyurethane gel layer that adheres to the skin surrounding the wound. On dry wounds or wounds having only slight discharge, the polyurethane gel layer can be adapted for use in direct contact with the wound by chemically altering the gel to increase its absorbency.
U.S. Pat. No. 5,115,801 to Cartmell et al., incorporated herein by reference in its entirety, discloses a multi-layer burn dressing having a hydrogel material layer that is placed in direct contact with the burn site on the skin. The hydrogel serves as a bio-compatible, bacterial protective, fluid absorbing, cushioned skin-like medium that facilitates the healing process.
Silicone gel sheets have also been applied directly to damaged skin to treat burns and scars, as disclosed, for example, in U.S. Pat. No. 4,991,574 to Pocknell, incorporated herein by reference in its entirety. In particular, silicone gels have been found to prevent keloid and hypertrophic scaring at wound sites and to reduce the visibility of existing scars. Such silicone gels are manufactured, for example, by Applied Silicon Corporation.
The aforementioned gel dressings are universally produced in flat sheets, with the gel material layer typically being secured to at least a substrate layer providing structural integrity to the dressing. One problem with such dressings is that, while these flat sheets are generally pliable and can be molded to a degree to conform to skin contours, such flat sheets have a limited ability to cover highly contoured skin surfaces of the body, e.g., the face, the scalp, the neck, the shoulders, the hands, the complete torso and/or upper body and arm(s), the complete lower body and/or leg(s), bent elbows and knees, hips, ankles, and feet. Consequently, these sheet-like dressing are generally most suitable for covering only a limited skin area. Further, due to their sheet-like shape, these dressings cannot generally form a secured enclosure to envelop a body part and therefore must rely almost exclusively on the adhesion of the gel material to remain secured to the body.
To cover highly contoured portions of the body, it would be necessary to cut pieces of the sheet dressing to suitable sizes and shapes, and to cover the wound in sections with plural dressing pieces. The set of individual dressing pieces might imperfectly cover the wound, and the cutting and application of customized dressing pieces would be time consuming and would make rapid application of the dressing virtually impossible. Further, this cumbersome operation would have to be performed each time the dressing is changed.
Burn dressings that are shaped to conform to certain portions of the body have long been known in the field. These dressings typically employ conventional wound-contact materials that are absorbent and permeable to fluid and air, such as gauze and fabric. For example, U.S. Pat. No. 3,343,537 to Graham, incorporated herein by reference in its entirety, discloses burn dressings for covering various anatomical parts. The dressings consist of a porous, multi-layer silk lining which comes into contact with the wound, and a multi-layer gauze backing.
U.S. Pat. No. 3,279,465 to Cherio et al., incorporated herein by reference in its entirety, discloses a bandage in the form of a vest having two short sleeves. The bandage consists of a net-like material that holds gauze in place over the wound.
U.S. Pat. No. 5,328,449 to Andrews et al., incorporated herein by reference in its entirety, discloses a wound dressing in the shape of a glove having a porous skin-contacting layer, an absorbent intermediate layer, and a outer layer formed of a water-proof breathable material.
While both gel materials and dressing garments have been used for many years in the treatment of burns and other wounds, to date, no known attempts have been made to develop a dressing garment that employs a skin-contacting gel material. This may be due in part to the fact that sheet-like, gel-based dressings are rather thick, heavy and awkward in comparison to the thin, lightweight, fabric-like materials conventionally used to form dressing garments, and the appearance and gummy, resilient feel of such bulky gel-based dressing sheets do not readily suggest the fashioning of garments from these dressings. The fact that sheet-like, gel-based dressings are conventionally applied via adhesion to a limited skin area, rather than as an enclosure that surrounds or drapes over a body part, further contributes to the perception that sheet-like, gel-based dressings do not lend themselves to use in garments and that these dressings may be ill-suited and impractical for such applications.
Moreover, sheet-like, gel-based dressings are functionally unrelated to conventional burn garments. Sheet-like, gel-based dressings are substantially impermeable to air and moisture, and have limited or no absorbency. The gel material is designed to essentially seal the wound and functions substantially as a synthetic layer of skin over the wound, preventing any external interaction. In contrast, conventional bum garments are formed of permeable, absorbent materials that remove and absorb fluids exuded from the wound. Unlike a synthetic skin, such garments function more as a separate, external covering that rests over the wound and encourages healing of the wound by permitting a controlled flow of air to the wound and a controlled removal of fluid from the wound.
These structural and functional differences between sheet-like, gel-based dressings and conventional burn garments would explain, at least in part, why these wound treatments have existed side-by-side in the field for years without any consideration of possible applications of gel materials in garment-like dressings.
It is an object of the present invention to provide a wound dressing designed to surround or drape over a highly-contoured body part or a combination of adjacent body parts to bring a gel material layer in direct contact with a skin wound located on the body part(s).
It is a further object of the present invention to reduce the time required to apply a dressing to a highly contoured portion of the body and to avoid the need to form a customized dressing at the time the dressing is to be applied to the wound.
It is another object of the present invention to provide a wound dressing garment that is adjustable in size to fit a portion of the body for bodies in a range of sizes.
It is yet another object of the present invention to rely on the combination of adhesion and conformance to body shape to secure a wound dressing garment to the skin of a patient.
Another object of the present invention is to provide a wound dressing garment that can be placed on a portion of the body and removed with a minimum of movement of the body and a minimal need to slide the garment over the body.
Yet another object of the present invention is to provide a wound dressing garment that is easily modifiable to apply a gel-like dressing only to the portion of the body requiring treatment.
The aforesaid objects are achieved individually and in combination, and it is not intended that the present invention be construed as requiring two or more of the objects to be combined unless expressly required by the claims attached hereto.
According to the present invention, a wound dressing garment includes an outer structure layer formed of a pliable material and an interior lining formed of a self-adhesive sheet-like structure made of a gel material which serves as a dressing for directly contacting wounds such as burns on a patient. The structure layer provides the overall shape of the garment as well as a framework for supporting the gel layer. The structure layer has at least two edge portions that are securable (i.e., either permanently secured or detachably securable) to each other to provide a partial enclosure suitable for enveloping a portion of the body.
The structure layer can include one or more layers of material and can be made of one or more of a variety of materials, such as fabric or elastomeric materials. The structure layer may include plural panels that are permanently secured to each other (e.g., via stitching, fusing or adhesive) along seams. Edges of the structure layer that are detachably securable to each other can be secured using conventional fastening mechanisms, such as hook and loop fasteners.
The self-adhesive, sheet-like gel layer serves as an interior lining of the wound dressing garment and is coupled to an inner surface of the structure layer over at least a substantial portion of the garment, such that the gel layer presents an interior surface for directly contacting the skin of the wearer. The gel layer has a soft, tacky texture and readily adheres to the skin but leaves no perceptible residue on the skin when removed. The gel material does not tend to significantly disturb newly formed tissue at the wound site when removed. Essentially, the gel material functions as a synthetic skin over the wound, allowing the wound to heal with a minimum of interaction with the external environment. By way of example, the gel material can be a silicone gel, a hydrogel or a polyurethane gel.
The gel layer can be directly secured to the structure layer by the inherent self-adhesiveness of the gel material, and/or the gel and structure layers can be bonded together by pressure, heat, or a suitable adhesive. An intervening layer can be disposed between the structure layer and the gel layer to secure the structure and gel layers to each other. The intervening layer can be an elastomeric material to which the gel layer readily adheres. The structure layer can be attached to the opposite side of the intervening layer by an adhesive or other suitable means.
The gel layer is covered with a protective thin, peelable layer, such as a plastic film, to prevent the gel layer from accidentally contacting other surfaces. In operation, the peelable layer is peeled off of the gel layer just before applying the gel layer to the skin of the wearer.
In accordance with one embodiment of the present invention, the wound dressing garment is made adjustable in size to snugly fit body parts of patients in a range of body sizes by allowing the edge portions of the garment to be secured in an overlapped fashion. In particular, the edge portions of the gel layer are preferably separable from the corresponding edge portions of the structure layer, such that the edge portions of the gel layer can be overlapped separately from the structure layer. Stated differently, the overlapping edge portions of the gel layer and the structure layer can be interleaved such that both gel layer edge portions underlie both structure layer edge portions, with one gel layer edge portion being secured to the other gel layer edge portion (or its intervening backing layer) and the edge portions of the structure layer being secured to each other via fasteners.
The gel layer can be permanently detached from the structure layer in the edge region, or the gel layer can be detachable from the structure layer in the edge region by tugging or peeling apart the structure layer and the intervening layer. Optionally, the structure layer can be detachable over its entire inner surface from the gel layer and/or an intervening layer. If a particular wound does not require a gel layer over the entire extent of the garment, this detachability feature allows portions of the gel layer to be selectively removed to improve the comfort of the garment, while the entire structure layer remains intact to provide complete support for the gel layer and to preserve the ability of the structure layer to secure the garment to the body.
The wound dressing garment of the present invention can be formed to cover any portion of the body, including any one, combination, or portion of the following body parts: fingers, hands, wrists, elbows, shoulders, arms, the head, the scalp, the face and individual facial features, the neck, the torso, the waist, hips, the groin, legs, knees, ankles, feet, and toes. Thus, the wound dressing garment of the present invention can be any one, portion or combination of the following garments: a finger wrap, a glove, a mitt, a sleeve, a vest, a jacket, a mask, a skull cap, a neck tube, a girdle, shorts, pants, leggings, a leg wrap, a sock or a toe wrap.
The above and still further objects, features and advantages of the present invention will become apparent upon consideration of the following detailed description of specific embodiments thereof, particularly when taken in conjunction with the accompanying drawings wherein like reference numerals in the various figures are utilized to designate like components.